Quality engineer

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
• Investigate Non-Conformances (Company) using root cause analysis and drive CAPA within the QMS framework.
• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.
• Collaborate with cross-functional teams to deliver quality-compliant outcomes.
• Interpret and apply medical device regulations and standards to projects and processes.
• Support audits and regulatory inspections, ensuring timely closure of action items.

Requirements:

• 5+ years of experience in Medical Device Quality & Compliance, with strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.
• Hands-on experience in:
  • Quality Management Systems (QMS)
  • Complaint Management
  • Post Market Surveillance (PMS)
  • Non-Conformance (NC)
  • Corrective and Preventive Action (CAPA)
  • Audits
• Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decision-making.